MILWAUKEE -- Over the last decade, a small group of prominent surgeons from around the country has been enlisted by medical device-maker Medtronic to do clinical research or write articles about the company's new spine surgery product.
In 2010 alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic spinal devices, according to a Milwaukee Journal Sentinel analysis of recently released company payments. Medtronic began disclosing the payments last year, in advance of a federal requirement set to take effect in 2013.
Since it won approval for narrow uses in 2002, the product -- bone morphogenetic protein-2, known as BMP-2 -- has been an increasingly dominant force in spinal fusion surgery, with sales of about $800 million a year, often for use in other procedures.
Independent doctors say the product's success is due largely to positive findings made by the surgeons affiliated with the company.
Doctors involved with two of the many research articles on BMP-2 published since it was approved -- one in 2002, the other in 2004 -- received a combined $6 million in royalties last year for other Medtronic spinal products, the newspaper found. The payments went directly to the doctors or business entities they are associated with.
"There is no question, if you have a product, you want it to be published," said Dan Spengler, former editor of a spinal medical journal and professor of orthopedic surgery at Vanderbilt University Medical School. "It carries weight."
There is no evidence any of the surgeons who have published articles on BMP-2 received royalties they did not deserve.
However, the spinal surgery field has been plagued by troubling questions about transparency.
For years, published articles revealed scant information about the financial conflicts of authors, including not spelling out how much royalty money an author received. Doctors say those articles have incalculable value to device-makers trying to increase sales of their products.
"That's really what delivers the most bang for the buck," said Charles Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine, and president of the Association for Medical Ethics.
But that impact is greatly diminished when doctors read that an author got a large amount of money.
"Compare the effect of reading, hypothetically, that one author received $5,000 in 2009 from Medtronic vs. reading he received $1 million," Rosen said. "The amount makes a difference."
In 2006, Medtronic agreed to pay $40 million to settle a U.S. Department of Justice lawsuit that alleged between 1998 and 2003 it paid kickbacks to doctors to induce them to use Medtronic spinal products. Among the forms of payments the government identified: Sham consulting agreements, sham royalty agreements and lavish trips.
In an e-mail, Medtronic spokeswoman Marybeth Thorsgaard said collaboration between doctors and the device industry is vital to medical technology innovation and has led to developments that have changed the lives of thousands of patients.
"Medtronic takes great care to ensure that all arrangements with physicians are fully compliant with the law and the industry's standards for such contracts," she said.
The company's relationships with doctors are transparent, she said, adding the company fully discloses those payments on its website.
At the time BMP-2 was approved in 2002, little was known about the financial connections between Medtronic and doctors associated with the clinical trial. Likewise, little was known that year when the Journal of Spinal Disorders & Techniques published the article on the trial.
The paper made no mention of doctors getting royalties or having any financial connection to the company.
However, in 2010 Medtronic began listing payments to doctors on its website, a practice that will become law when the Physician Payment Sunshine Act goes into effect in 2013.
The Journal Sentinel used that database to check payments made last year to a core of prominent doctors who have published research about BMP-2 since its approval.
Three of the four authors of a 2004 article on the study of the product are listed as receiving nearly $4 million last year in royalties from Medtronic for a variety of spinal products, not BMP-2.
That paper was important because it involved a clinical trial that had to be stopped because the product was causing troubling bone formation in the spinal canal of patients. In the paper, that finding was downplayed, with the authors describing the results as "encouraging."
Spengler, the Vanderbilt orthopedic surgeon and former medical journal editor, said he doubted the paper would have been written in such positive terms by authors without financial ties to Medtronic.
He described the article as egregious, saying it "just blew off the complications. It's a horrible article."
Orthopedic surgeon Rosen said the paper was biased, calling it "more of a marketing paper than an objective scientific study."
BMP-2 became a blockbuster product because it eliminates the need for removing a small amount of hip bone from patients, which is then used as a graft in doing spinal fusion surgery. The product has revolutionized the field because of its ability to essentially turn whatever it touches into bone -- a good thing if confined to the tiny space between vertebrae.
However, there have been concerns about serious side effects, especially when the product is used in what are known as off-label surgeries, that is, purposes other than for what it originally was tested and approved.
About 85 percent of BMP-2 use now is off-label, according to recent studies.
Said Spengler: "It (the article) seems to be totally aimed at promoting BMP-2 off-label without really saying so."
The article described three of the authors as consultants to Medtronic, though it did not disclose that any of them were receiving royalties at the time.
Regis Haid, lead author of the article and an Atlanta neurosurgeon, told the Journal Sentinel he was getting royalties for other Medtronic products. Haid noted disclosure rules for medical journals have become more stringent in recent years.
He said BMP-2 provides excellent benefit to patients, adding he had it implanted in his own neck in an off-label procedure. "I have BMP in me, and I would put it in you," he told a reporter.
Through September, Haid and Spinal Engineering LLC received about $2 million in royalties last year from Medtronic.
Meanwhile, co-author Ken Burkus, a Columbia, Ga., surgeon, and RBCK Research & Consulting, received $573,000.
"Very importantly, you cannot assume that such royalty payments were made prior to 2010," he said in an e-mail, declining to say whether he got royalties at the time the paper was written. "I follow the rules to my fullest ability as put forward by the specific journal."
He took issue with criticism that the paper put a positive spin on a troubling clinical trial.
"I believe the words used were appropriate," he said. "I believe the words used were neither 'positive nor negative' but rather were representative of the data presented."
He said if other doctors have problems with the paper, they should take it up with the editor of the journal: "They can write a letter to the editor."
Co-author Charles Branch Jr., chairman of neurosurgery at Wake Forest University, and the university itself have received $1.2 million in royalties last year.
A spokeswoman for the university said it owns the intellectual property rights to Branch's patents and that royalties generally are split with 35 percent to the individual and 65 percent to the university. None of those royalties involved BMP-2, university media relations manager Bonnie Davis said in an e-mail.
She said Branch and Wake Forest were getting royalties at the time the paper was published, but not when the trial was going on.
In a separate e-mail, Branch said use of term "encouraging" in the paper "was not a strong endorsement," but, rather, recognition that patients getting BMP-2 had superior results to those receiving a traditional bone graft.
The clinical trial that ultimately led to FDA approval of BMP-2 focused on another type of spinal fusion surgery.
The four co-authors of a 2002 paper about that trial received a total of $2.8 million in 2010 from Medtronic in royalties for products not including BMP-2.
The paper made no mention of any financial relationship between the authors and Medtronic.
Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.
Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.
Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.
Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.
He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.
The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.
Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.
In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.
Another surgeon, Thomas Kleeman of New Hampshire, was not an author the 2002 paper but co-authored a 2009 paper on the BMP-2 clinical trial and also is listed as an author on an abstract on the clinical at the 2007 North American Spine Society meeting.
Kleeman, who did not return phone calls, received $56,000 in royalties in 2010.
(c) 2011, Milwaukee Journal Sentinel.
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